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news.Boston Scientific, a medical device company, has received approval from the Japanese Ministry of Health, Labor and Welfare to market its Taxus Liberte paclitaxel-eluting coronary stent system.
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According to the company, the Taxus Liberte is the only second-generation drug-eluting stent approved for use in Japan. Design improvements over the company’s first-generation Taxus Express2 stent include thinner struts to allow better stent deliverability and conformability, as well as a more uniform stent geometry for consistent lesion coverage and drug distribution.
The Taxus Liberte stent uses paclitaxel-eluting technology, which has been evaluated by the industry’s most extensive randomized, controlled clinical trial program, and studied in 35,000 real-world patients enrolled in post-approval registries. The company plans to launch the product as soon as reimbursement approval is granted, which is expected shortly.
The Taxus Liberte stent will replace the Taxus Express2 stent, which was launched in Japan in May 2007. It has been approved for sale in the US, Europe and other international markets, the company said.
Jim Tobin, president and CEO of Boston Scientific, said: We are very pleased with this approval, which provides access to proven technology to Japanese physicians and their patients. We are committed to continuing to provide the most innovative products and therapies to the Japanese market.